510(k) K210476 ยท FCG Biopsy Needle
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, May 20, 2021 |
| Received | Feb 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Open, Classified |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.